Qualitest Pharmaceuticals Issues a Nationwide Recall of All Accusure® Insulin Syringes

Qualitest Pharmaceuticals today issued a voluntary nationwide recall of all Accusure® Insulin Syringes. The distributed syringes are of the following descriptions and NDC numbers: 28G 1/2cc, NDC 0603-6995-21;28G 1cc, NDC 0603-6996-21; 29G 1/2cc NDC 0603-6997-21, 29G 1cc, NDC 0603-6998-21, 30G 1/2cc, NDC 0603-999-21, 30G 1cc, NDC 0603-7000-21, 31G 1/2cc, NDC 0603-7001-21; and 31G 1cc, NDC 0603-7002-21. All Accusure® Insulin Syringes regardless of lot number are subject to this recall. These syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots may have needles which detach from the syringe.

If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection.

Consumers who have any Accusure® Insulin Syringes should stop using them and contact Qualitest at 1-800-444-4011 for reimbursement. You can find the lot number on the white paper backing of each individual syringe.

Qualitest is notifying all customers who received these syringes and arranging for the return of any affected product.

The recall is being made with the knowledge of the Food and Drug Administration.

Consumers with questions may contact Qualitest at 1-800-444-4011 for more information.

Adverse reactions or quality problems experienced with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either on line, by regular mail or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/medwatch/getforms.htm
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 1-800-FDA-0178

Evidence is emerging to suggest that patients need to be alert to the fact that combining nonsteroidal anti-inflammatory pain medications (NSAIDs) such as ibuprofen (ADVIL) and naproxen (ALEVE) with a class of osteoporosis drugs called bisphosphonates, such as alendronate (FOSAMAX), etidronate (DIDR¬ONEL), ibandronate (BONIVA) and risedronate (ACTONEL) may result in an increased risk of ulcers and other gastrointestinal side effects and complications.

In the article, “Preserving Bones with Bisphosphonates: Should You Avoid NSAIDs?”- Worst Pills Best Pills, one randomized study of 26 healthy subjects looked for stomach ulcers in people who were given three short-term (10-day) treatments with alendronate, naproxen, and both together. Subjects were given all treatments with a one-to four-week washout between each. Eight percent of the people who took alendronate alone developed a stomach ulcer, and 12 percent of patients who took naproxen alone also developed a stomach ulcer. The study found that 38 percent of patients who took the two drugs together developed a stomach ulcer. There was a dramatic increase in the risk of stomach ulcers, demonstrating what is called synergism between the two drugs.

A larger study also examined the medical records of 242 patients who had received NSAID therapy for rheumatoid arthritis over a three-month period and found that over 30 percent of the patients receiving bisphosphonates along with their NSAID therapy had developed gastrointestinal ulcers, compared to 17 percent in those who received NSAIDs alone.